Standard: HHS - 21 CFR PART 310

NEW DRUGS

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Scope:

Definitions and interpretations.

As used in this part:

(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321–392).

(b) Department means the Department of Health and Human Services.

(c) Secretary means the Secretary of Health and Human Services.

(d) Commissioner means the Commissioner of Food and Drugs.

(e) The term person includes individuals, partnerships, corporations, and associations.

(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 310
Publish Date: 2016-04-01
Page Count: 46
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 310 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 310 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV

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